FDA Clears AiViva Biopharma's AIV001 for Intradermal Injection in Nonmelanoma Skin Cancer

AiViva Biopharma Inc., a clinical-stage biotechnology company based in Costa Mesa, California, has recently announced the receipt of FDA clearance to test AIV001 (axitinib) via intradermal injection on facial skin. AIV001, designed as a pan-tyrosine kinase inhibitor in a proprietary formulation for extended drug release, is currently being developed to evaluate its efficacy in treating Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC).

The FDA clearance follows AiViva’s provision of safety data demonstrating non-facial skin tolerability, efficacy, and systemic exposure in 67 subjects who had been treated with AIV001 for Basal Cell Carcinoma (BCC) and in scar management. According to Dr. Diane Tang-Liu, President and CEO of AiViva, this regulatory milestone paves the way for the development of AIV001 in areas of cosmetically sensitive skin, including the face, neck, and scalp. Dr. Tang-Liu emphasized the potential of AIV001 to become the first therapeutic specifically developed for treating facial skin areas affected by sBCC or nBCC lesions, expressing optimism about the product’s future due to its backed intellectual property and focal delivery method.

AiViva has already completed three clinical studies involving the intradermal injection of AIV001. In these studies, participants received one to three treatments, each spaced three weeks apart. Results showed that the prolonged drug release and potency of AIV001 in the skin led to both clinical and histological clearance of biopsy-confirmed BCC lesions in 26 patients. Furthermore, in two trials involving scar models, 41 subjects were treated, and it was observed that a single intradermal injection of AIV001 reduced fibrosis formation over surgical incisional wounds. These findings indicate AIV001’s potential application in scar management. Darlene Deecher, AiViva’s Vice President of Clinical Development, highlighted the significance of these achievements in advancing AIV001’s clinical development and expanding its evaluation for use in dermatological conditions.

About AiViva Biopharma Inc.

AiViva Biopharma Inc. is a clinical-stage biotechnology company driven by a team of experienced industry professionals with a strong track record in drug development and commercialization. The company focuses on devising innovative approaches to address unmet medical needs by revolutionizing treatment paradigms through focal therapies targeting diseases associated with neovascularization, abnormal cell proliferation, and fibrosis. AiViva’s core strengths lie in developing novel drugs utilizing proprietary technologies, such as JEL®, across specialty therapeutic areas including dermatology, ophthalmology, urology, and oncology.

AIV001 is currently an investigational product candidate under clinical development. Its efficacy and safety profiles are not yet established, and it has not been approved for marketing by the Food and Drug Administration.